ID

44314

Descrição

Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC; ODM derived from: https://clinicaltrials.gov/show/NCT00755534

Link

https://clinicaltrials.gov/show/NCT00755534

Palavras-chave

Versões (2)
  1. 28/12/2017 28/12/2017 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00755534

Inglês

Eligibility Colorectal Cancer NCT00755534

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed locally advanced or metastatic colorectal cancer
Descrição

Colorectal Cancer Advanced Locally | Colorectal cancer metastatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0948380
measurable or evaluable disease according to the response evaluation criteria in solid tumors (recist)
Descrição

Measurable Disease | Evaluable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
ecog performance status ≤ 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
age 18 - 72 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients who have had a cr, pr or sd after 1st line therapy based on irinotecan+bevacizumab
Descrição

In complete remission Post First line treatment | Partial response Post First line treatment | Stable Disease Post First line treatment | irinotecan | bevacizumab

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1708063
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1708063
UMLS CUI [3,1]
C0677946
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1708063
UMLS CUI [4]
C0123931
UMLS CUI [5]
C0796392
paraffin block from the primary tumor in order to perform tha mutational analysis of the kras gene
Descrição

Paraffin Block Primary tumor | KRAS gene targeted mutation analysis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519524
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C4264276
adequate liver (bilirubin ≤ 1.5 upper normal limit, sgot/sgpt ≤ 4 upper normal limit, alp ≤ 2.5 upper normal limit),renal (creatinine ≤ 1.5 upper normal limit) and bone marrow (anc ≥ 1,500/mm3, plt ≥100,000/mm3) function
Descrição

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
UMLS CUI [8,1]
C0005953
UMLS CUI [8,2]
C0031843
UMLS CUI [9]
C0948762
UMLS CUI [10]
C0032181
patients must be able to understand the nature of this study
Descrição

Comprehension Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of central nervous system or brain metastases
Descrição

CNS metastases | Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220650
pregnant or lactating woman
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
life expectancy < 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
previous radiotherapy within the last 4 weeks or > 25% of bone marrow or in the field where the treatment target is located
Descrição

Prior radiation therapy | Therapeutic radiology procedure Bone Marrow Percentage | Radiotherapy, Targeted

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0439165
UMLS CUI [3]
C0205918
peripheral neuropathy grade ≥2
Descrição

Peripheral Neuropathy CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
known hypersensitivity to erbitux
Descrição

Hypersensitivity Erbitux

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1173436
metastatic infiltration of the liver >50%
Descrição

Infiltration metastatic Liver Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332448
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0439165
patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
Descrição

Chronic diarrhea | Partial bowel obstruction | Total colectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2]
C1328480
UMLS CUI [3]
C0192871
active infection
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
Descrição

Second Primary Cancers | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
psychiatric illness or social situation that would preclude study compliance
Descrição

Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Colorectal Cancer NCT00755534

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Cancer Advanced Locally | Colorectal cancer metastatic
Item
histologically confirmed locally advanced or metastatic colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0948380 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease according to the response evaluation criteria in solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age 18 - 72 years
boolean
C0001779 (UMLS CUI [1])
In complete remission Post First line treatment | Partial response Post First line treatment | Stable Disease Post First line treatment | irinotecan | bevacizumab
Item
patients who have had a cr, pr or sd after 1st line therapy based on irinotecan+bevacizumab
boolean
C0677874 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1708063 (UMLS CUI [1,3])
C1521726 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C0677946 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1708063 (UMLS CUI [3,3])
C0123931 (UMLS CUI [4])
C0796392 (UMLS CUI [5])
Paraffin Block Primary tumor | KRAS gene targeted mutation analysis
Item
paraffin block from the primary tumor in order to perform tha mutational analysis of the kras gene
boolean
C1519524 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C4264276 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate liver (bilirubin ≤ 1.5 upper normal limit, sgot/sgpt ≤ 4 upper normal limit, alp ≤ 2.5 upper normal limit),renal (creatinine ≤ 1.5 upper normal limit) and bone marrow (anc ≥ 1,500/mm3, plt ≥100,000/mm3) function
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0005953 (UMLS CUI [8,1])
C0031843 (UMLS CUI [8,2])
C0948762 (UMLS CUI [9])
C0032181 (UMLS CUI [10])
Comprehension Study Protocol
Item
patients must be able to understand the nature of this study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases | Metastatic malignant neoplasm to brain
Item
presence of central nervous system or brain metastases
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy
Item
life expectancy < 3 months
boolean
C0023671 (UMLS CUI [1])
Prior radiation therapy | Therapeutic radiology procedure Bone Marrow Percentage | Radiotherapy, Targeted
Item
previous radiotherapy within the last 4 weeks or > 25% of bone marrow or in the field where the treatment target is located
boolean
C0279134 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0205918 (UMLS CUI [3])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy grade ≥2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity Erbitux
Item
known hypersensitivity to erbitux
boolean
C0020517 (UMLS CUI [1,1])
C1173436 (UMLS CUI [1,2])
Infiltration metastatic Liver Percentage
Item
metastatic infiltration of the liver >50%
boolean
C0332448 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Chronic diarrhea | Partial bowel obstruction | Total colectomy
Item
patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
boolean
C0401151 (UMLS CUI [1])
C1328480 (UMLS CUI [2])
C0192871 (UMLS CUI [3])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Second Primary Cancers | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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